§314.540. Postmarketing safety reporting.
21 C.F.R. § 314.540
Drug products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved drug products, as provided in §§ 314.80 and 314.81.
Notes, amendments, and revision history
Source
Source: 57 FR 58958, Dec. 11, 1992, unless otherwise noted.
Authority
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1.
Source
Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.